Kornimate/medical-research-clean huggingface dataset:
ct analysis of the patellofemoral joint in patients having knee surgery

Conditions: Patellar (or Kneecap) Instability and Mal-alignment

Summary: the primary hypothesis is that measures of patellofemoral alignment obtained from the investigational cone beam ct scanner will be reduced, but still correlated to those obtained from the conventional ct scan.


Eligibility criteria:
inclusion criteria: * patients who have been diagnosed with acute or chronic patellar malalignment. * at least 16 years old * be willing and able to provide informed consent exclusion criteria: * open growth plates * previous knee surgery on the affected knee * pregnancy (females) * fracture of the patellofemoral joint * knee ligament injury (other than medial patellofemoral ligament) * have greater than grade ii degenerative changes of the patellofemoral joint * inability to bear weight on the extremity during the ct scan
safety and efficacy of pagibaximab injection in very low birth weight neonates for prevention of staphylococcal sepsis

Conditions: Staphylococcal Sepsis

Summary: evaluate the safety, pk and efficacy comparing pagibaximab injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23.

phase 2b/3, randomized, double-blind, multicenter, placebo-controlled study evaluating the safety, efficacy and pharmacokinetics (pk) of pagibaximab (100 mg/kg/dose) in comparison to placebo for the prevention of staphylococcal sepsis in vlbw infants (600 -1200 grams). subjects monitored for treatment related adverse events and tolerability to infusion of study drug. neonatal sepsis will be assessed in the presence of clinical signs and symptoms and one blood culture positive for s. aureus or two blood cultures positive for coagulase negative staphylococci (cons). the study period will be 35 days after the first dose or until, death, discharge, or transfer, whichever occurs first.

Eligibility criteria:
inclusion criteria: 1. in-patient at a neonatal intensive care unit (nicu) 2. informed consent obtained from the legally authorized representative 3. less than 48 hours old at the time of first infusion 4. birth weight between 600 grams and 1200 grams 5. estimated gestation age ≤33 weeks for multiple gestations, twins may be enrolled if they each meet the entry criteria. they will both be assigned to the same treatment group. exclusion criteria: 1. infants with history of a hypersensitivity or severe vasomotor reaction to any antibody preparation. 2. infants with proven staphylococcal infection prior to randomization. 3. infants with a concomitant infection or other medical condition, whose participation, in the opinion of the investigator and/or medical advisor, may create an unacceptable additional risk. 4. immunodeficiency other than due to prematurity. 5. currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study. 6. severe congenital or chromosomal anomaly that would limit life expectancy or required corrective measures during the period of this study 7. uncontrolled seizures

Keywords: staphylococcal coagulase negative staphylococcus monoclonal antibodies very low birth weight infants prophylaxis
lagb as a treatment for morbid obesity in adolescents

Conditions: Morbid Obesity; Obstructive Sleep Apnea Syndrome; Metabolic Syndrome; Insulin Resistance; Nonalcoholic Fatty Liver Disease

Summary: laparoscopic adjustable gastric banding (lagb) has been used worldwide to help selected morbidly obese adults to lose weight. the fda has approved lagb only for patients 18 years or older. our hypothesis that lagb can be used to assist selected adolescents between 14 and 17 years lose weight and that the procedure can be performed safely in this age group. we are also evaluating the effects of weight loss after lagb on known comorbid conditions such as sleep apnea syndrome and insulin resistance, and also on psychological health.

seventy to ninety-eight percent of obese children become obese adults. comorbidities of obesity such as type ii diabetes, fatty liver disease, hyperlipidemia, hypertension, asthma, sleep apnea, and depression are becoming increasing common in adolescents as more adolescents become obese. the only consistently durable and effective weight loss programs for the morbidly obese patients are those that include bariatric surgical procedures. the investigators believe that the best initial bariatric surgical option for adolescents is lagb because of its low complication rates, adjustability, and reversibility. obese adolescents ages 14-17 who meet criteria for entry will be enrolled to determine the degree of success of lagb as measured by % excess weight loss, decreased % body fat, decreased body mass index (bmi), reduction in comorbid conditions, and metabolic parameters (including serum lipids and glucose tolerance) at intervals of 3 months, 6 months, 1 year, then annually for a total of 5 years postoperatively. eligible patients will have been followed for 6 months by physicians in the center for adolescent bariatric surgery and: 1) will attended a minimum of 75% of visits and 2) will have failed to lose at least 20% of excess weight. following evaluation by the team (which will include evaluations by a nutritionist, an endocrinologist, a psychologist/psychiatrist, a pediatric nurse practitioner, and a surgeon) a patient may be offered lagb.

Eligibility criteria:
inclusion criteria: * ages 13-17 upon entry * bmi \>40 or \>35 with associated medical comorbidities (e.g., sleep apnea, hypertension exclusion criteria: * severe psychiatric illness * eating disorder with purging * previous weight loss surgery * stated inability to comply with pre-op and post-op visits

Keywords: adolescent obesity surgery bariatric surgery adjustable gastric banding
defining the molecular risk in israeli patients with secondary compared to primary myelofibrosis

Conditions: Myelofibrosis, Primary; Myelofibrosis, Post PV; Myelofibrosis, Post ET

Summary: the aim of the study is to determine the rate of hmr mutations in pmf and secondary mf (post pv/et) subjects, and correlate the rate of mutations with clinical features as known prognostic scores.

main inclusion criteria: 1. diagnosis of pmf, post pv mf or post et mf according to the who 2008 classification 2. age ≥ 18 years 3. concurrent participation in clinical trials will be allowed. efficacy assessments will be evaluated by: hmr mutations rate, specific hmr mutations, disease duration, presence of splenomegaly, cytogenetic risk, dipps, ipss, et survival score and pv survival score. the primary efficacy parameter to be assessed will be hmr mutation rate.

Eligibility criteria:
inclusion criteria: 1. diagnosis of pmf, post pv mf or post et mf according to the who 2008 classification 2. age . 18 years 3. patient is willing and capable of giving a written informed consent. 4. concurrent participation in clinical trials will be allowed exclusion criteria: 1. unwilling or unable to provide informed consent 2. prefibrotic mf
multicenter clinical observation promos®

Conditions: Primary and Secondary Omarthrosis

Summary: overall study design: this study is a prospective, multicenter, postmarket clinical observation to validate the promos™ standard shoulder system as state-of-the-art implant system for total shoulder arthroplasty in terms of radiographic and clinical performance as well as long-term survivorship over 10 years.

primary objective: radiological and clinical loosening rates of the glenoid and humeral components must be comparable or below the rates of other well documented state-of-the-art shoulder systems with cemented glenoid components. complications occurring intra- or postoperatively will be assessed and sub-classified in their relation to the implant. at the end of the observation, a long-term survival rate will be calculated according to kaplan-meier with revision due to aseptic loosening as the end-point. secondary objectives: the constant murley score and the ases clinical evaluation are used for documenting the improvement in pain, function and range of motion. for the patient's subjective view of improvement in function a patient self-assessment form is used.

Eligibility criteria:
inclusion criteria: * patient has no general medical contraindication to surgery * informed consent to participate in the observation signed by the patient * routine radiographic assessment is possible * patient is likely to comply with study follow-up requirements * primary total- or hemi-shoulder-arthroplasty to the affected side, unilateral or bilateral exclusion criteria: * acute shoulder trauma * tumor / malignoma * avascular necrosis * late stage rotator cuff disease * charcot joint disease or other severe neurosensory deficits * high comorbidity * previously failed shoulder arthroplasty * fracture sequelae of proximal humerus * hypersensitivity to the implant materials used * addictive disorders such as alcohol or drug abuse * severe spinal disorders * bacterial infections
effect of jnj 31001074 on urge to drink in alcohol-dependent adults

Conditions: Alcoholism

Summary: the purpose of this study is to assess whether jnj-31001074 taken for 7 days reduces the urge to drink alcohol in alcohol-dependent study participants who are not seeking treatment.

this study will evaluate whether jnj 31001074 reduces the urge to drink alcohol in non treatment seeking, adult study participants with current alcohol dependence. individuals who meet criteria for study participation will be randomly assigned to one of two treatment groups (tablets containing jnj 31001074 or placebo tablets with no active ingredients) in a 1:1 ratio. treatment group assignment will not be known by study participants or study staff. baseline assessments will be recorded and participants will return to the clinic for testing on the last day of taking their assigned study medication for 7 days at home. alcohol use is not allowed for 3 days prior to this end-of-dosing testing. during this test, their urge to drink alcohol and their mood will be measured while they view various computer images and then are presented with (but do not drink) either a favorite alcoholic beverage or water. other measures will be collected during the study to evaluate the safety and tolerability of the study medication, including potential effects on sleep, as well as measures of thinking and cigarette smoking. participants will return for a follow-up visit approximately 1 week after finishing the study medication and completing the clinic assessment above. study participants will take one 3-mg tablet of jnj-31001074 or matching placebo in the morning, preferably with food, for 7 days.

Eligibility criteria:
inclusion criteria: * male or female * currently alcohol dependent but not seeking treatment * meets study criteria for amount of alcohol consumed * otherwise healthy * urge to drink increased by the presence of alcohol * able to complete and understand questionnaires and study procedures in english * willing and able to comply with the study requirements, including a 3-day period of alcohol abstinence and use of highly effective contraceptive methods * signed informed consent. exclusion criteria: * pregnant or breast-feeding * significant medical or psychiatric conditions other than alcohol dependence * history of, or at risk of, medically significant alcohol withdrawal syndrome * dependent on substances other than alcohol , nicotine or caffeine * smokes more than 1 pack of cigarettes per day or consumes more than 500 mg caffeine per day * has glaucoma, cataracts, a history of eye inflammation, eye injury, or eye surgery other than to correct vision * treatment in the past 1 month prior to screening with disulfiram (antabuse), acamprosate (campral), naltrexone (revia or vivitrol), or topiramate (topamax) * in need of or currently taking any psychoactive medications

Keywords: alcoholism alcohol-related disorders substance-related disorders mental disorders alcohol dependence jnj-31001074 bavisant
study of photobiomodulation effect on electroretinogram outcomes in dry age-related macular degeneration

Conditions: Age Related Macular Degeneration

Summary: to evaluate the ability of photobiomodulation (pbm) treatment using the valeda® light delivery system to improve electroretinogram (erg) outcomes in subjects with dry age-related macular degeneration (amd).

this study is an open label, prospective pilot study to evaluate retinal function after pbm treatment in eyes with dry amd using erg. the target enrollment is 15 subjects in up to two sites in the us. all subjects will receive pbm treatment. subjects will receive three pbm treatments per week for three weeks for a total of nine sessions over 3 weeks. the primary analysis will examine multi-focal erg function changes from baseline to month 1. secondary analyses will examine multi-focal erg function change from baseline to month 3 and 6. other endpoints will include other functions of erg, etdrs visual acuity, contrast sensitivity, perimetry, color vision test and the amsler grid test.

Eligibility criteria:
inclusion criteria: * male or female at least 50 years of age at screening visit * etdrs bcva letter score of between 50\* and 75\* (snellen equivalent of 20/100 to 20/32) * diagnosis of dry amd * able to communicate well with the investigator and able to understand and comply with the requirements of the study * informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines exclusion criteria: * current or history of neovascular maculopathy * presence of center involving ga within the central etdrs 1 mm diameter at screening * media opacities, including cataracts, which might interfere with visual acuity or imaging in the study eye(s) * posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s) * invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to screening * visually significant disease in any ocular structure apart from dry amd * serious medical illness that will prevent the subject from performing study activities * presence of or history of malignancy within the past 5 years * presence or history of known light sensitivity to yellow light, red light, or near infrared radiation (nir), or if they have a history of light activated cns disorders (e.g. epilepsy, migraine) * history of neurologic condition known to affect visual function * history of drug, alcohol or substance abuse within 3 months prior to screening * participation in any other clinical study at time of screening, or has received an investigational drug or treatment with an investigational device within 3 months prior to screening * in the opinion of the investigator, is unlikely to comply with the study protocol
bone marrow autotransplantation in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: this project evaluates the effectiveness of the administration of autologous bone marrow blood in patients with brittle type 1 diabetes mellitus to restore insulin secretion. after mobilization of hematopoietic progenitors (g-csf) during 3 days, 50 to 90 ml of bone marrow blood will be obtained by multifunction in the posterior iliac crest. the material obtained will be implanted into the pancreas through the magna pancreatic artery after femoral catheterization.


Eligibility criteria:
inclusion criteria: * diabetes type 1 patients * 18 to 50 years of age * more than 5 years of evolution of the disease * brittle diabetes (hba1c \> 8.5 % with intensified treatment or severe hypoglycemia episodes exclusion criteria: * history of cancer * hematologic alterations * infectious disease positivity (hiv, hcv etc.) * diabetic nephropathy * cardiac failure * liver disease * autoimmune systemic disease * allergy to iodine contrast or anesthesia

Keywords: diabetes type 1 bone marrow transplantation
er:yag laser treatment for female stress and mixed urinary incontinence (incontilase)

Conditions: Female Stress Urinary Incontinence; Mixed Incontinence, Urge and Stress

Summary: the purpose of this study was to evaluate the effect of a non-invasive er:yag thermal laser therapy in treating female stress and mixed urinary incontinence.

urinary incontinence (ui) is a common disorder that affects women of various ages and impacts all aspects of life. therapeutic approaches range from conservative therapy, which is heavily dependent on patient compliance, to different, more invasive, surgical procedures. the aim of the study was to evaluate the non-invasive erbium:yttrium-aluminum-garnet (er:yag) laser treatment (incontilase) as a potential treatment strategy for stress ui (sui) and mixed ui (mui). the treatment works by thermally affecting vaginal mucosa, with an emphasis on the anterior vaginal wall, resulting with partial denaturation of collagen fibres and stimulation if new collagen formation, all of which leads to firmer support for the urethra and the improvement of incontinence symptoms. the investigators included 175 women with newly diagnosed sui (66% of women) and mui (34 %), respectively and performed on average 2.5±0.5 procedures in each woman separated by a two-month period, using er:yag laser. patients were clinically examined and classified by incontinence types (sui and mui) and grades (mild, moderate, severe and very severe) using international consultation on incontinence modular questionnaire (iciq) and assessing incontinence severity index (isi): isi before the therapy was 5.7±2.1 points. treatment discomfort was measured at every session with visual analogue system pain scale, and adverse effects and patients' satisfaction were followed. follow-ups were performed at two, six and twelve months after the treatment.

Eligibility criteria:
inclusion criteria: * clinically confirmed ui * normal pap smear (papanicolaou cytology) * negative urine culture * integrity of the vaginal mucosa (without injuries or bleeding) exclusion criteria: * pregnancy * intake of photosensitive drugs * vaginal injuries or vaginal bleeding * infection in the treated area * clinical diagnosis of pure urge urinary incontinence

Keywords: urinary incontinence er:yag laser
study of nivolumab combined with ipilimumab versus pemetrexed and cisplatin or carboplatin as first line therapy in unresectable pleural mesothelioma patients

Conditions: Mesothelioma

Summary: the purpose of this study is to test the effectiveness and tolerability of the combination of nivolumab and ipilimumab compared to pemetrexed and cisplatin or carboplatin in patients with unresectable pleural mesothelioma.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * males and females at least 18 years of age * histologically confirmed pleural malignant mesothelioma not eligible for curative surgery * ecog performance status of 0 or 1 * available tumor sample for testing * acceptable blood work exclusion criteria: * primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas * prior chemotherapy for pleural mesothelioma * prior treatment with an anti-pd-1, anti-pd-l1, anti-pd-l2 oranti-ctla-4 antibody * history of other malignancy unless the subject has been disease-free for at least 3 years * active, untreated central nervous system (cns) metastasis other protocol defined inclusion/exclusion criteria could apply
dexamethasone reduces postoperative emesis by decreasing pgf2α and ltc4 levels

Conditions: Thyroid Cancer; Breast Cancer

Summary: hypothesis: dexamethasone reduces postoperative emesis in thyroidectomy and mastectomy patients.

this study has been done to further study the effectiveness of dexamethasone in the prevention of postoperative emesis after breast and thyroid surgery and at the same time, the mechanism of action was investigated. in this prospective, randomized controlled trial it was hypothesized that corticosteroids exert their antiemetic effects in postoperative period via plasma prostaglandin f2 alpha (pgf2 α) and plasma leukotriene c4 (ltc4) inhibition.

Eligibility criteria:
inclusion criteria: * breast and thyroid cancer patients no neoadjuvant treated no nsaid or steroid usage heallthy volunteers, signed the informed consent exclusion criteria: * ones who did not sign the consent form nsaid or steroid users

Keywords: thyroid cancer breast cancer dexamethasone emesis
axillary block or wide-awake local anesthesia for complex regional pain syndrome (crps) following common hand surgeries

Conditions: CRPS; Walant; Axillary Block

Summary: flare reaction, characterized by excessive erythema, stiffness, and edema postoperatively, can lead to complex regional pain syndrome (crps) when pain is present. this study compares flare and crps incidence following hand surgeries performed under regional anesthesia with axillary block (raab) and walant (wide-awake local anesthesia no tourniquet).

this two-center prospective study included patients undergoing dupuytren contracture (dc), dequervain tenosynovitis (dqs), carpal tunnel syndrome (cts), and trigger finger (tf) surgeries under raab or walant. diagnostic criteria for flare and crps (pain, weakness, scar issues, erythema, and swelling) were assessed, and comorbidities were noted. the incidence of flare reactions and crps was compared for raab and walant.

Eligibility criteria:
inclusion criteria: * patients diagnosed with and operated on for dupuytren contracture (dc), * patients diagnosed with and operated on for de quervain tenosynovitis (dqs), * patients diagnosed with and operated on for carpal tunnel syndrome (cts), * patients diagnosed with and operated on for trigger finger (tf) exclusion criteria: * patients operated under general anesthesia, * patients operated with other types of regional anesthesia (eg: supraclavicular block), * patients operated with other types of local anesthesia (only prilocaine or bupivacaine) * patients less than 3 months follow up

Keywords: crps flare reaction walant axillary block